Find out which stories shook the world of biopharma this year.

Big money, big data, and some big layoffs made the biggest headlines in biopharma during 2013. So did big layoffs by big pharma, and a big political squabble that resulted in NIH and FDA closing most of their doors for 16 days. Below are details of these and more of the biggest biopharma developments of the past 12 months.

DIRECT-TO-CONSUMER TESTING: FDA Calls Out 23andMe

The FDA laid the proverbial hammer on direct-to-consumer gene testing pioneer 23andMe in November, ordering the company to stop selling its Saliva Collection Kit and Personal Genome Service (PGS), while obtaining agency approval to market the $99 “spit kit.” The company promised to comply, while adding it will continue to provide consumers both ancestry-related information and raw genetic data without interpretation, continue conducting research using its database of genetic and phenotypic data, and maintain its educational efforts.

In a warning letter to 23andMe, FDA’s Center for Devices and Radiological Health (CDRH) said it considered PGS as being “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” The enforcement action drew sharp criticism from free-market advocates who echoed 23andMe and its CEO Ann Wojcicki in arguing the tests were not diagnostic in nature, but intended only to furnish data upon which health decisions could be based. In responses posted on the company’s blog, critics also accused FDA of attempting to stifle innovation for the benefit of big pharma and doctors—an argument denied by Commissioner Margaret A. Hamburg, M.D., who contended the agency’s sole focus was ensuring patient safety.

Both sides have reduced their rhetoric in recent days, with Wojcicki acknowledging her company had not communicated proactively enough with FDA, and the agency insisting it’s not trying to kill DTC genetic testing. That’s usually the first sign of a meeting of minds, but whether that happens won’t be apparent until next year at the earliest.

Hepatitis C saw a few new drugs approved by FDA—including Olysio (simeprevir) from Johnson & Johnson’s Janssen Pharmaceuticals unit, while Gilead Sciences’ treatment Sovaldi (sofosbuvir) could boast that it was the first drug to ever show sufficient safety and efficacy to treat certain types of HCV infection without the need for injection of interferon at the same time.

Earlier this year Janssen won FDA marketing authorization for Invokana (canaglifozin) tablets, the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved as a diabetes treatment; the drug is indicated for adults with type 2 diabetes. FDA approved three Takeda drugs for type 2 diabetes in a single day in January—Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.

GlaxoSmithKline (GSK) and Theravance won the agency’s nod for the chronic obstructive pulmonary disease (COPD) drug Breo Ellipta, a once-daily inhalable drug that is expected to rack up blockbuster-level sales of more than a billion dollars—sales GSK will need in order to recoup losses expected in a few years once generic versions of its best-selling product, Advair, reach the market.

Among cancer drugs approved this year were Celgene’s Pomalyst (pomalidomide) for multiple myeloma, while Roche’s Genentech subsidiary won authorization to market Gazyva (obinutuzumab or GA101), in combination with chlorambucil chemotherapy for people with previously untreated chronic lymphocytic leukemia (CLL)—the first drug on which FDA bestowed its “Breakthrough” designation. Genentech also won FDA’s approval for the Herceptin-DM1 combination drug Kadcyla (T-DM1 or ado-trastuzumab emtansine), for patients with HER2-positive, metastatic breast cancer. GSK hit the proverbial trifecta in May, as FDA approved two of its melanoma drugs—Tafinlar (dabrafenib) and Mekinist (trametinib)—and a companion diagnostic designed to detect the gene mutations expressed by the tumors each treatment is designed to fight. Bayer and Algeta won FDA approval for their prostate cancer drug Xofigo in May, six months before Bayer offered to buy its partner for about $2.4 billion.

Cancer drugs account for 22% of Phase III pipelines among top-25 drug companies, and 30% of Phase II, according to a Decision Resources report released in November.

GENE PATENTING: Myriad of Lawsuits

Companies looking to patent human genes won a mixed verdict from the U.S. Supreme Court in June, when the justices unanimously ruling that Myriad Genetics’ claims for seven patents related to breast cancer susceptibility genes BRCA 1 and 2—but also holding that companies can patent composite DNA (cDNA) and other synthetic genetic material that does not meet the “Product of nature” exemption from patentability.

While some experts predicted a rush of competition leading to plunging prices for genetic tests, Myriad refused to roll over, instead vigorously defending its remaining 17 BRCA patents by suing, one-by-one, several of its rivals on infringement grounds: Ambry, Gene by Gene, Gene Dx, Quest Diagnostics, Invitae, and most recently, Laboratory Corporation of America (LabCorp). “It seems that the Supreme Court’s decision has really spurred Myriad to defend its perceived IP as much as possible against these companies,” much as Amgen successfully held off rivals for its erythropoetin products a decade ago, noted George Yu, an attorney with the law firm Schiff Hardin, told GEN.

“There isn’t a case that comes to mind for diagnostics, and maybe that’s somewhat due to the ability to diagnose conditions and diseases in certain ways. It would seem you would need some portion of the BRCA gene to diagnose susceptibility to breast cancer due to your BRCA genotype,” Yu added.

Myriad also rolled out new tests. In September, the company launched its myRisk Hereditary Cancer™ test, a 25-gene panel covering eight major cancers (breast, colorectal, endometrial, gastric, melanoma, ovarian, pancreatic, and prostate) at an average selling price of $3,700. In October the company introduced myPlan™ Lung Cancer, which carries a $3,400 list price; followed in November by myPath™ Melanoma, which has an average selling price of $1,500. By 2015, Myriad has said, it expects to discontinue several current tests, including the BRACAnalysis test at the center of the Supreme Court case.

IPO MARKET: Revival at Last

The initial public offering (IPO) market finally delivered on years of revival hype by roaring back in 2013, with no less than 55 therapeutic, diagnostic, and industrial/agricultural biopharma companies going public this year as of December 10. According to data by Burrill & Co., they raised a combined $6.236 billion, one third of which came from the year’s single largest IPO, Zoetis, Pfizer’s animal-care spinout, with more than $2.2 billion raised. Zoetis was followed by CRO Quintiles ($525 million raised); and eye disease drug developer Ophthotech ($167 million).

“A lot more money is coming into the sector,” Edward Ahn, Ph.D, managing director and CSO of MedCap Advisors, told GEN. The revival of the overall market was definitely one factor, since it brought more generalist investors back to make investments, he said. Yet investors also responded to FDA’s quickening pace of review and decisions on new drugs, aided by last year’s enactment of the 2012 Food and Drug Administration Safety and Innovation Act; and what Dr. Ahn said was a scarcity of quality companies in which to invest.

He said another factor in the IPO revival was the Jumpstart Our Businesses (JOBS) Act, whose provisions include a five-year exemption from the Sarbanes-Oxley Act and confidential IPO pricing for smaller companies issuing their first public shares: “The regulations have really helped some small companies take their company public.”

JOBWATCH: Layoff-Go-Round Continues

Round and round big pharma cost-cutting goes, and where (and when) the layoffs stop, nobody knows. Merck & Co. wielded the sharpest axe in 2013, when it said October 1 it will eliminate 8,500 jobs worldwide by the end of 2015, as part of a restructuring that will include shrinking its real estate footprint in New Jersey and moving its headquarters within the Garden State.

Not far behind, AstraZeneca announced it was shedding an additional 3,900 additional jobs—2,300 selling, general, and administrative (SG&A) employees plus 1,600 R&D staffers. Those layoffs brought to 5,050—roughly 10% of the current workforce—the number of positions to be jettisoned through 2016. Also eliminating large numbers of jobs were Eli Lilly (1,245 U.S. sales reps due to expected patent-cliff revenue losses); Novartis (nearly 1,000 jobs at Ciba Vision, a consumer drugs plant in Lincoln, NE, and most recently 325 R&D staffers); and Endo Health Solutions (about 700 jobs, after failing to stop a generic version of its Opana ER [oxymorphone HCl] moderate-to-severe pain drug from reaching the market).

The biggest layoff wave not to occur was the 5,000-job elimination announced by Teva in October. Israeli officials reacted with thunderous criticism, and the company withdrew its plans some three weeks later—a factor speculated as leading to the CEO’s resignation (See NOTABLES, on page 2).

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